The FORUM February Seminar: a report

On 29 February a seminar on SPCs was held in London under the auspices of FORUM Institut für Management GmbH (as noted by The SPC Blog here). The two speakers were the German authors/practitioners Christopher Brückner and Peter von Czettritz, whose book on SPCs was published last year by Carl Heymanns. Following this event we are fortunate to have received this report on it:

"The seminar was divided into four parts directed to the issues (the numbers cited in brackets refer to the speakers' book):. 

I. The Concept of the Product, 

II. Material and Formal Requirements for an application, 

III. Paediatric Extension of Duration and finally 

IV. Scope and Effect of an SPC. 

I. The Concept of the Product 

The product is the pivotal element of the SPC system. It is important to note that definitions and restrictions which are directed to the product as such are product-related (Article 1, §68). The following example illustrates this point: 

According to Article 7(1) of Regulation 469/2009 (article of this SPC Regulation for Medicinal Products are cited below as ArtM), the application for a certificate shall be lodged within six months of the date on which the authorisation to place a product on the market was granted. This means that after the first Marketing Authorisation within the member state of the application has been filed, the deadline starts to run. If two competitors try to get a Marketing Authorisation for the same product, and both competitors want to file an SPC, the deadline for both applications are triggered by the earlier Marketing Authorisation. 

The same has to be said regarding requirements of ArtM 3d. If an application for an SPC is filed, the Marketing Authorisation on which this application is based must be the first Marketing Authorisation within the member state. Once again, if two competitors get two Marketing Authorisations for the same product and both competitors file an application for an SPC, both applications must be based on the earlier of the two Marketing Authorisations. 

Another issue was the possibility to get an SPC for a derivative of the product (Article 1,  §§ 87 to 98). If an SPC has been granted for a product and the applicant wants to get an SPC for a derivative of the product, the first requirement according to recital 14 of the Regulation 1610/96 is that the derivative is subject-matter of a separate patent protection. However, according to the Decision Triptorelin ( 14 W (pat) 9/06) of the Federal Patent Court (Article 1, §100) an SPC for this derivative can only be granted if the derivative is a product different from the product for which the SPC has been granted. To prove this difference, the applicant should present arguments that the derivative has pharmacological properties different from the pharmacological properties of the product. 

II. Material and Formal Requirements for an Application 

As a consequence of the CJEU decision in Case C-322/10 Medeva, for the first time it is possible to file an application for an SPC for a product which is different from the product for which the underlying Marketing Authorisation has been granted. The court decided there that an SPC can be granted for a combination of two compounds, if a Marketing Authorisation is presented which has been granted for more than two compounds. Subsequently Case C 422/10 Georgetown University clarified that an SPC can be granted even for one single compound if a Marketing Authorisation is presented which is directed to more than one compound. 

The term “specified” used in this decision caused further discussion regarding the questions, how the product of an SPC has to be defined in the basic patent. However, it is very likely that this issue will be the subject matter of a further Referral to the CJEU. 

Moreover, the special case of passive certificates, i.e. certificates based on third parties Marketing Authorisations, was discussed (Article 6, §§ 57 to 69). In Novartis v Medimmune [2012] EWHC 181 (Pat) of the High Court, this issue was discussed for the first time by a Court (§61). Perhaps, this question will be the subject-matter of a further Referral to the CJEU. 

III. Paediatric Extension of Duration 

The objective of the Paediatric Regulation is to ease the development and accessibility of medicinal products for use with the paediatric population. This objective is achieved by a system of obligations, rewards and incentives, where multiple incentives are ought to be excluded. An extension of duration is a reward with respect to ArtPd. 36. 

The general preconditions for an application for extension of duration were shown with regard to the respective form sheets of the German Patent and Trademark Office and the Intellectual Property Office, UK (Form SP4). Also it was shown for application deadlines to vary with respect to status of the application procedure. On the other hand, in the case of waiver, class waiver or deferral according to ArtPd. 7(1(b) to (d) an extension of duration is not possible. 

In the case of a new field of application of significant clinical benefit against existing therapy it may also be applied for a one year extension of data exclusivity (Art. 10(1) 2001/83). Here the company has to choose exclusively between one more year of data protection or a 6 month extension of duration. If market exclusivity was granted to orphan drugs according to Art. 8(1) 141/2000, there is no extension of duration (ArtPd. 26(4)). 

A controversial question in the field is whether studies which were conducted accordingly to the agreed paediatric investigation plan, must have been conducted by the holder of the patent or protection certificate or if the results of third party studies can be used instead. Although considering the intention of the Paediatric Regulation, the consequence of admissibility of use of third party studies and a missing analogy to the decision Biogen/ SmithKline, the question is yet not decided. 

IV. Scope and Effect of an SPC. 

Incidentally, on the same day the CJEU answered the Referral in Case C-442/11, directed to the question of the effects of a mono SPC against combination products, this issue was intensively discussed during the seminar. 

Principally, an SPC has the same effects as the underlying patent. The restriction to the product, introduced by the reference to ArtM 4 of the Regulation, only has an effect if the subject-matter of the patent and the SPC are different. In other words: If a basic patent simply protects one product, and an SPC has been granted for this one product, the subject-matter of the basic patent and the SPC are the same. Due to ArtM 5, in that case, the effects, i.e. the protection against a mono-product or a combination product are the same. As a consequence, an SPC directed to a mono-compound also protects against the use of this compound in combination with other compounds. The effect of the reference of ArtM 5 to 4 is the exclusion of non-pharmaceutical use and non-authorised use (Article 4, §§32 to 54). 

Finally, the protective effects of pending protection certificates were discussed (Article 5,  §§ 152 to 179). This question so far has not been the subject-matter of a court decision. However, it has to be assumed that the fact that an SPC was not granted for an admissible application should not be used against the applicant. 

Finally, a very interesting question was asked by the audience. We forward this question to the SPC blog as the Question of the Day: 

The question is the following: according to ArtM 5 an SPC should confer the same rights as conferred by the basic patent. As a consequence, the effects of an SPC must not be broader than the effect of the respective basic patent. For example, an SPC for a compound A cannot be granted if the basic patent claims only A plus B. If such an SPC was granted, the SPC, in addition to the effects of the basic patent, would also protect against A, A plus C and so forth. So far, this is more or less undisputed. 

However, if a basic patent claims A and A plus B, and an SPC has been granted for A plus B, does this SPC protect also against A? 

We are very keen to receive the answers of the members of the SPC blog on this question.

We have learned that two further SPC seminars are being offered by the FORUM Institute. One seminar, in English, will be held on 4 and 5 October 2012 in Amsterdam.  A second seminar, in German, will be held on 23 and 24 October 2012 in Frankfurt. Further details will be provided once they are available.

Late renewal: when the computer can't be blamed

In Tulane Education Fund v Comptroller General of Patents [2012] EWHC 932 (Pat) Roger Wyand QC, sitting on 17 April as a Deputy Judge of the Patents Court, England and Wales, heard an appeal against the refusal of a UK Intellectual Property Office hearing officer to reinstate a supplementary protection certificate following the applicant's failure to pay the prescribed fees in time.

Tulane's basic patent for Cetrorelix expired on 10 July 2008 and the SPC was due to come into effect the next day. Dennemeyer & Co had been instructed to pay Tulane's SPC fees. Having failed to pay the prescribed fee within the prescribed period, Dennemeyer sought to pay it within the six months immediately following the prescribed period in reliance on the Patents Act 1977 Sch.4A para.5, using the electronic patent, design and trade marks renewal system at the same time as it made 3,075 other payments for various other patent renewals. Unfortunately the SPC number was converted into a patent number by the IPO's computer system, which did not recognise it as a valid patent number, with the result that the payment was rejected. Dennemeyer did not realise which application had been rejected because the reference number had been changed, and the error was realised only after the period for late payment for the prescribed fee had expired.

Tulane then applied to the Intellectual Property Office for a correction of an irregularity under the Patents Rules 2007 r.107 or for the SPC to be brought into effect under s.28(1) of the Act ("Where a patent has ceased to have effect by reason of a failure to pay any renewal fee, an application for the restoration of the patent may be made to the comptroller within the prescribed period"). The hearing officer rejected Tulane's applications and the company appealed.

In its appeal Tulane submitted that (1) the IPO erred in relying on a computer system which erroneously changed the reference number of the SPC and rejected it, and in failing to send an adequate response in relation to the rejection of the payment; (2) the hearing officer should have restored the lapsed certificate under s.28 since that provision applied to SPCs as well as patents; (3) Sch.4A para.5 was ultra vires as it was intended to implement Regulation 1768/92 and a requirement for a single payment could not fall within the provision in Art.12 of the Regulation allowing "annual fees".

Roger Wyand QC dismissed the appeal. In his view the electronic payment system used by Dennemeyer was intended for patent payments and not for SPC payments. A computer program's attempt to interpret a reference number by converting it into a format appropriate for the payments for which the system was intended could not therefore be described as an error. The IPO was obliged to send a rejection, quoting the number used in the payment application, when it rejected that payment and that failure did contribute to the failure to pay the appropriate fee in time. However, the failure to identify the payment that was rejected accurately did not actively bring about Dennemeyer's failure to pay the fee: Dennemeyer had not followed the Rules and paid via the appropriate system for a SPC -- and it could have worked out the change in reference number. In terms of causation Roger Wyand QC added that, even if the error had not occurred, it was doubtful that the correct fee would have been paid in time. Accordingly, the IPO's error was not sufficiently causative to enable the application of r.107(3). For the avoidance of all doubt, he added that s. 28 had no application in the case of SPCs.


Source: note published on the Lawtel subscription-only service

At last -- the invitation!

We promise it won't be anything like this ...!

It's not often that The SPC Blog can say, in all honesty, "this is what you've all been waiting for" -- but this is one of those occasions. The SPC Blog's 2012 seminar will take place on Tuesday 22 May, once again in the congenial surroundings of Olswang LLP's London office (thanks!). This is the fourth annual seminar and we look forward both to welcoming old-timers and to seeing some fresh faces.

Registration begins at 1.30pm and the seminar itself kicks off at 2.00pm.  Speakers are Dr Dolores Cassidy (Irish Patents Office), Dr Micaela Modiano (Modiano & Partners), Hugh Goodfellow (Carpmaels & Ransford) and Michael Burdon (Olswang LLP).

Lots of fun is promised, not to mention the traditional refreshments that conclude the seminar, for which admission is free.

You can access the invitation and full programme here. For further enquiries and to RSVP, please email Danielle Maidana-Power at danielle.maidana-power@olswang.com

Atripla in Poland: a recent ruling on "product" and claim construction

Katarzyna Zbierska has kindly drawn our attention to this piece which was published in Special IP issue of the Bulletin of her law firm, Kochański Zięba Rąpała i Partnerzy:

"The Polish Supreme Administrative Court applies the definition of a “product” in the light of the CJEU’s judgments in the “Medeva” and “Georgetown” cases and Polish principles on patent claim construction

In its recently published reasoning to the judgment of 14 February 2012, the Polish Supreme Administrative Court (“SAC”) explains the grounds for upholding the judgment of the District Administrative Court in Warsaw (“DAC”), which ruled that the decision of the Polish Patent Office (“PPO”) on renouncing to grant an SPC for an antiretroviral product was correct. 

Merck & Co., Inc applied for an SPC for an antiretroviral product (“Atripla”) based on Polish patent PL 176679, which encompassed a new compound I or II and one nucleoside analog. The PPO stated that the basic patent concerned a product consisting of two active ingredients, whereas an SPC application concerned a product consisting of three active ingredients: efavirenz, emtrycitabine and tenofovir dizoproxil. The PPO decided that the product cannot be identified in the basic patent and tenofovir dizoproxil is a nucleotide analog whereas the subject matter of the basic patent is nucleoside analog. Since the patent claims do not refer to nucleotide analog or nucleoside analog prodrugs, the PPO decided that tenofovir dizoproxil does not fall within the claims of the basic patent. As a result, the PPO refused to grant an SPC. 

Merck challenged the argumentation raised by the PPO that patent claims, in particular in the case of inventions in the field of chemistry, may not be construed literally. Furthermore, the basic patent also covers products which consist of three active ingredients since the second ingredient specified in the patent claims has a functional character, thus encompasses any compounds which are biologically active. Claim construction applied by the PPO excessively limits the scope of the patent protection. The PPO does not take into account that patent protection encompasses not only ingredients indicated in the claims but also additional features, thus any combination of such ingredients may be considered a product qualifying for an SPC. 

According to Merck the claim no. 1 of the basic patent specifies a combination of ingredients having a formula I or II (in this case – efavirenz) with nucleoside analog being a reverse-HIV-transcriptase inhibitor (in this case nucleoside analog is: emtricitabine and tenofovir disoproxil fumarate). The claim does not refer only to one nucleoside analog since nucleoside analog reverse-HIV-transcriptase inhibitor concerns a group of compounds defined functionally. When editing patent claims a singular is commonly used, which however does not limit patent protection just to a single solution. The application of a nucleotide analog in combination which, after administration to a patient, transforms into a nucleoside analog falls into claim no.1 of the basic patent. The nucleotide analog is a nucleoside analog prodrug and is an equivalent to the solution covered by the basic patent.

The DAC upheld the PPO’s decision and decided that the claims of the basic patent concern a combination of active ingredients to prevent HIV infection characterized by that it is a combination of a formula I or II or pharmaceutically acceptable salts of formula I or II, with a nucleoside analog being a reverse-HIV-transcriptase inhibitor. According to the DAC, the basic patent covered only a two-ingredient combination: a combination of formula I or formula II with a nucleoside analog reverse-HIV-transcriptase inhibitor. The three-ingredient product being a combination of efavirenz, emtricitabine and tenofovir dizoproxil does not fall within the patent claims. One cannot derive from a teaching of the patent that it should cover more than two active ingredients. Neither do patent claims contain any “nucleotide analog” or “nucleoside analog prodrugs”. As a formula I, a formula II, their salts or nucleoside inhibitor one may use different compounds expressed by a particular formula or a functional name, though there will always be only two ingredients. Tenofovir dizoproxil fumarate is an additional active ingredient which renders the product new comparing to that included in the basic patent, beyond its scope of protection. 

Merck appealed the DAC’s verdict to the SAC which dismissed the appeal. According to the SAC, the scope of protection of the basic patent is determined by its claims. The Patent description and drawings should support claim construction, however, these are claims which are decisive when determining the scope of the patent protection. This means that claims should be construed literally and only what one can construe based on a patent document has a meaning. There is no basis to construe patent claims to the extent which a patent applicant did not take care of himself and seek protection which extends over the literal meaning of claims. This applies also to equivalents. It is important to remember that patent protection is not only a privilege for a patent owner but a limitation for others which should not encroach upon patent monopoly. Therefore, there must be and are limits of patent protection and this case has indicated this precisely. 

Granting an SPC over a product which is not entirely protected by the basic patent would in fact be contrary to Art. 3a of Regulation 1768/92. The SAC referred at this point to the judgments of the Court of Justice of the European Union of 24 November 2011 in cases C-322/10 (“Medeva”) and C-422/10 (“Georgetown”), in which the CJEU held that Art. 3a of the Regulation precludes the PPO from granting an SPC to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application. Art. 3b of the Regulation does not preclude the PPO from granting an SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on where the medicinal product for which the marketing authorization is submitted in support of the SPC application contains not only that combination of the two active ingredients (in the “Georgetown” case, C -422/10 – “that active ingredient”), but also other active ingredients. As a result, the material patent law has not been infringed in this case when determining scope of protection of the basic patent. 

According to the SAC, the subject matter of the basic patent is: a combination of two active ingredients, where active ingredient I is a particular compound I or II or their salt, and active ingredient II is a functional compound - nucleoside analog being a reverse-HIV-transcriptase inhibitor. Therefore, the second active ingredient must be from a group of nucleoside analog reverse-HIV-transcriptase inhibitors, however, one cannot derive from the claims of the basic patent that the combination may include two different nucleoside analogs, i.e. include a third active ingredient being another nucleoside analog. The basic patent did not encompass a combination of three active ingredients: efivarenz (compound indicated expressly in the patent claims), emtricitabine (nucleoside analog), tenofovir dizoproxil fumarate (nucleotide analog which transforms in a human body into another nucleoside analog). As a result, an SPC could not be granted for such a product which extends over the literal meaning of patent claims of the basic patent and thus does not meet the requirements under art. 3(a) of Regulation 1768/92".

Analysis of SPCs affected by Medeva

GenericsWeb recently undertook an analysis of all SPCs where the subject is a combination (with an expiry date after 01/01/2012), checking the underlying patents to see whether they protected all components of the combination specifically. They came up with some surprising results. The findings were presented at the European Generics Association legal affairs forum earlier this year, and are available in an article published in Generics Bulletin (here). You can also get a copy of the slides presented at the meeting by writing to y.bretonnet@genericsweb.com

Many thanks to Leighton Howard (GenericsWeb) for letting us know!

Seminar news

The SPC Blog pays particular attention
to getting the right alchemy for its seminars...

The programme for The SPC Blog Seminar, which Olswang LLP has kindly agreed once again to host in its London office, is nearly ready to go. The official programme and invitation will be posted very soon.  In the meantime, you might like to see how it's shaping up.

The date arranged for this year's event is Tuesday 22 May and the programme will look something like this:

13.30 Registration
14:00 Chairman's introduction
14:10 Medeva - the fall-out
14:35 SPC protection in Italy
15:00 Break
15:20 Neurim - the hearing and AG's opinion
15:40 SPCs, the central European patent and court
15:55 Medeva around the world and -- though this remains in the realms of possibility rather than certainty -- the SPC quiz!
16:20 Questions

Drinks and refreshments will then follow.

Don't respond to this post: just wait a bit and RSVP to the formal invitation!

The Neurim hearing: an eye-witness account

Francisco Bernardo Noriega (Partner, ABG Patentes, Madrid) is a patent attorney who works mainly in the field of pharmaceuticals. He recently attended the hearing before the Court of Justice of the European Union (CJEU) in the Neurim referral (Case C-130/11; see earlier SPC Blog posts here, here and here) which, in his view, deals with a number of interesting issues of SPC law. The case, he notes, is being closely followed by interested parties, as was evident by the surprisingly high number of members of the public attending in Luxembourg, including people from the pharmaceutical industry, solicitors and attorneys. This is what he writes:

“On 15 March 2012, the CJEU heard parties in connection with the C-130/11 Neurim Pharmaceuticals preliminary reference from the Court of Appeal for England and Wales. The reference concerns the interpretation of Articles 3(d) and 13 of the SPC Regulation (EC Regulation 469/2009) and, more particularly, the circumstances in which these Articles mean that an earlier marketing authorisation (“MA”) precludes an SPC based on a subsequent MA. In making the reference, the Court of Appeal had endorsed Neurim’s arguments in strong terms (“We consider that Neurim’s arguments are not only tenable: in our view they are right”), holding that Articles 3(d) and 13 should not preclude Neurim’s SPC, but that Neurim’s arguments needed endorsement by the CJEU:

“In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU’s highest court.”

Neurim, the UK Government, the Portuguese Government and the Commission appeared at the hearing in front of five judges (Jean-Claude Bonichot, Konrad Hermann Theodor Schiemann, Camelia Toader, Alexandra Prechal and Egidijus Jarašiunas) with Verica Trstenjak as the Advocate General.

Neurim and the Commission were united in arguing that an earlier MA should be taken into consideration (under Article 3(d) or Article 13) only if its subject-matter is within the scope of the basic patent (with reference to Article 4 which limits the scope of the SPC to being no broader than the basic patent). Both parties referred to the underlying scheme and objectives of the Regulation, highlighting the importance of incentivising the type of research which Neurim had undertaken and the consequences of not providing such incentives. They also drew distinctions over the existing case law (C-31/03 Pharmacia, C-431/04 MIT and C-202/05 Yissum etc.); they also emphasised that Neurim’s proposal for the operation of Articles 3(d) and 13 has never before been the subject of a CJEU judgment, and would allow the SPC regulation to meet its purpose, as defined in the recitals.

Neurim also referred to Recital 14 of Regulation 1610/96 (which is explicitly valid under Recital 17 for interpreting the medicinal product SPC Regulation), pointing out that failure to find in Neurim’s favour would deprive Recital 14 of its effet utile. Recital 14 states that an SPC can be granted for a patented salt even if there is an earlier SPC for the same active substance which would, were it not for Recital 14, block the second SPC (because, in such a case, the two active ingredients (“products”) are the same). In making this argument, Neurim referred to C-392/97 Farmitalia to demonstrate that one salt of a particular active ingredient is considered as having the same active ingredient (“product”) as another salt of the same active ingredient (or indeed the active ingredient in its non-salt form). Thus Neurim argued that Recital 14 could not operate properly if the CJEU rejected Neurim’s arguments because, if Neurim’s arguments were rejected, there would be situations where an earlier MA necessarily precludes an SPC based on a subsequently patented salt.

The UK argued that the CJEU has to find against Neurim because the CJEU’s existing case law constrains it from reaching any other conclusion. The UK referred in particular to C-31/03 Pharmacia, C-431/04 MIT and C-202/05 Yissum in addition to the recent cases of C-195/09 Synthon and C-322/10 Medeva. On Medeva, the UK argued that because the CJEU permitted an SPC to be based on an MA which refers to active ingredients (“A + B”) not specified within the scope of the patent (to “A”), it follows that Neurim is wrong. In reply, Neurim argued that the CJEU’s comments in Medeva (which formed the basis of the C-422/11 Novartis reasoned order) are entirely consistent with Neurim’s position because the CJEU confirmed that an SPC to “A” can be used to oppose “A + B” (i.e. “A + B” is within the protection conferred by an SPC to “A”, in accordance with patent law). On Synthon, the UK relied on the comments in AG Mengozzi’s opinion, and both the Neurim and the Commission put forward counterarguments.

The UK and Portugal also argued that Neurim’s approach could lead to evergreening. Both Neurim and the Commission disagreed, highlighting that any SPC granted under Neurim’s approach (which requires the basic patent not to extend to the subject-matter of the earlier MA) could not, by reference to Article 4, cover the subject-matter of the earlier MA. They therefore argued that the second SPC could not prevent the free movement of the earlier-authorised medicinal product within the European Community.

The Portuguese Government also considered that SPC availability in cases like Neurim would be contrary to TRIPS.

Neurim also argued that, if the CJEU answers the first three referred questions against it, then an SPC should nonetheless be allowed in those cases where the subsequent formulation/use requires a full marketing approval dossier (“Initial/Global Marketing Authorisation” according to art. 6(1) Directive 2001/83). Neurim highlighted the distinction between Initial/Global Marketing Authorisations as defined under European Pharmaceutical regulation and other authorisations which merely involve variations (and which, unlike an Initial/Global Marketing Authorisation, do not give rise to data exclusivity periods). This is reflected in the fourth question referred to the CJEU.

The Advocate General’s opinion is expected in May 2012, with the actual judgment of the Court likely to be issued several months later".

Thanks so much for this note, Francisco, which paints a colourful picture of the positions taken in this intriguing reference.